Means for disposal of articles by flushing and ostomy pouches particularly suited for such disposal

ABSTRACT

Flexible, soft objects such as ostomy pouches, wound dressings, bandages, diapers, etc. can be flushed down a conventional toilet by covering the article with a sheet of material which rapidly becomes slimy or exudes a slimy material on contact with the water in a toilet bowl or by adding such materials directly to the bowl. An ostomy pouch constructed from materials particularly suited for disposal in a toilet bowl is also disclosed. The pouch is constructed from laminates of water swellable, cold water insoluble films and water resistant tissue paper.

BACKGROUND OF THE INVENTION

At the present time, commercially available disposable articles such asostomy pouches, diapers, bandages, sanitary napkins, tampons, etc., aredisposed of by placing the soiled article in a garbage receptacle whereit is collected on a daily, bi-weekly, or other regular basis. Thismethod of disposal while not totally convenient is particularly awkwardwhen the user is away from home, for example, at work or at a publicfacility. Clearly, it would be a benefit to provide a means fordisposing of such articles by flushing in a conventional toilet.However, the user must be confident that the article will be flushed andpass through the plumbing system. The following are previous examples ofsuggestions for accomplishing these results.

Kiefer in European Pat. No. 10,171B discloses a flushable,disintegratable ostomy pouch made from a multi-layer foil. The innerlayer which contacts the body waste is a water-insoluble film-formingmaterial such as polyethylene. The middle layer is of a water solublematerial such as polyvinyl alcohol or partially saponified polyvinylacetate. The outer layer may have water-repellent characteristics and bea material which disintegrates in water when additionally subjected tomechanical means such as kraft paper.

Samways et al. in British Pat. No. 2,083,762 B disclose a disposableostomy pouch formed of a composite sheet material comprising anoutwardly-presented mechanically strong, backing layer which has goodtensile strength and cohesion when dry but which is dissolved ordispersed when immersed in mildly turbulent water and aninwardly-presented mechanically weak but water-impermeable layer. Theouter layer can be a low wet strength paper or preferably a plastic filmsuch as polyethylene oxide or polyvinyl alcohol. The polyvinyl alcoholmay be plasticized and may be a hot-water soluble grade. Materialssuitable for forming the water-impermeable layer include polyvinylidenechloride, Saran, nitrocellulose, waxes, pressure sensitive adhesive forexample a solution of rubber latex in an organic solvent, etc.

Galindo in U.S. Pat. No. 3,089,493 discloses a colostomy bag having adisposable liner. The disposable bag consists of an outer layer of papercoated with a rather insoluble material.

Scheier in U.S. Pat. No. 3,790,067 discloses a container having an innerlayer of water-insoluble material and an outer layer of water solublepolymeric material such as polyvinyl alcohol. The outer layer comprisesthe load-bearing member and the inner layer is sufficiently thin to beshredded under normal atmospheric forces or by the weight of thematerial in the container.

Watson et al. in U.S. Pat. No. 3,886,112 disclose a plastic compositionconsisting of partially hydrolyzed polyvinyl alcohol resin with agelling amount of a water soluble borate salt. The material is insolublein small volumes of water or body fluids but soluble in large volume. Itcan be formed into film and various shaped objects such as sanitarynapkin barrier films.

Wilkins in U.S. Pat. No. 3,762,454 discloses a disposable garbagecontainer which will degrade in situ in a garbage dump. The container ismade of a laminate of cold water soluble polyvinyl alcohol and hot watersoluble polyvinyl alcohol.

Potts in U.S. Pat. No. 4,372,311 disclose disposable articles made fromwater soluble polymers coated with a degradable water-insoluble polymersuitable for use in diapers, catamenial devices, sanitary napkins,bandages, etc. The water soluble polymer is selected from poly(alkyleneoxide), hydroxyethyl cellulose, hydroxypropyl cellulose, polyvinylalcohol, polyvinyl pyrrolidone, etc. The degradable water-insolublepolymer is selected from a cyclic ester polymer, a poly (β-hydroxybutyrate), dialkanoyl polymers, and ethylene polymers.

Holmes in U.S. Pat. No. 4,620,999 discloses a disposable bag made from3-hydroxybutyrate or a laminate of 3-hydroxybutyrate and polyvinylalcohol or polyethylene oxide. Basic material is provided to modify thepH of the bag contents to at least 12 so that the bag will disintegrateand can be flushed.

Oberstein in No. WO 80/01374 discloses a flushable bedpan made ofplastic material that dissolves in water of a temperature of less than60° F. but will not be dissolved by water or liquid above 60° F. Thewater soluble plastic material is a modified hydroxypropyl cellulose.

Procter & Gamble Co. in British Pat. No. 1,312,370 discloses shortfibered airfelt pads used as the absorbent layers in disposable articlessuch as diapers, sanitary napkins, etc., which are disposable by toiletflushing.

National Polymers and Chemical Corp. in British Pat. No. 1,271,424disclose disposable bedpan liners consisting of a base film 11 of awater disintegratable or cold water soluble polyvinyl alcoholpolymerization product, a thin water-insoluble coating 12, and a singleply tissue paper 13 of toilet tissue grade. In another embodiment, theother side of base film 11 is covered with a layer of paper which isstrong when dry but of weak wet strength.

SUMMARY OF THE INVENTION

This invention is directed to means and methods enabling the disposal ofvarious articles by flushing in a conventional toilet system. The meansinvolves providing a slimy layer which lubricates and/or softens thearticle thus assuring its passage through the plumbing system. Suitablemeans include wrapping or enclosing the article within a material thatbecomes slimy or exudes a slimy material when in contact with the waterin a toilet bowl. This result can also be accomplished by coating thearticle with a lubricating and/or softening substance prior to placementwithin the toilet bowl or adding such substances directly to the toiletbowl just prior to flushing.

Another object of this invention is the construction of an ostomy pouchfrom materials selected so that the ostomy pouch can be reliablydisposed by flushing in a conventional toilet. The pouch is formed ofmaterials which in use maintain their structural integrity. However,after flushing through the conventional toilet, the pouch softens andbecomes flexible so that it can break up and tear on its way to amuniciple sewer system or eventually degrade within a septic system.

The pouch material is preferably a laminate of a water resistant tissuepaper layer and a layer of a hot water soluble film such as polyvinylalcohol film. When formed into the ostomy pouch configuration, the hotwater soluble film will be the interior pouch layer.

Another aspect of this invention is such flushable ostomy pouch having adeodorizing filter for the release of flatus that builds up within thepouch. The filter is located in an upper portion of the pouch above thestomal opening. The filter is isolated from the remainder of the pouchby means of a heat seal except for a gap that permits gas to travel intothe filter area. The heat seal prevents any material that flakes offfrom the filter from falling into the waste collection portion of thepouch and from falling onto the stoma that protrudes into the pouch.

According to a further aspect of this invention, the flushability of theostomy pouch formed from the laminate described above is enhanced by useof the means described above.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a bag formed of materials that willprovide a lubricating effect to an article placed therein. The bag isshown in its open configuration prior to insertion of the article to beflushed.

FIG. 2 is a front view of an ostomy pouch particularly suited fordisposal by flushing as it would be applied to the body of the user.

FIG. 3 is a front view of the rear panel of such ostomy pouch.

FIG. 4 is a side view of the front panel of such ostomy pouch in greatlyenlarged detail prior to its being joined to the rear panel.

FIG. 5 is a side view of a modified front panel suitable for such ostomypouch in greatly enlarged detail prior to its being joined to the rearpanel.

FIG. 6 is a side view of the rear panel of such ostomy pouch in greatlyenlarged detail prior to its being joined to the front panel.

FIG. 7 is a front view of an ostomy pouch also suited for disposal byflushing and having a modified adhesive faceplate. This view shows thepouch as it would be applied to the body of the user.

FIG. 8 is a front view of an ostomy pouch similar to that shown in FIG.2 but including means to permit the pouch to be torn prior to disposal.

DETAILED DESCRIPTION OF THE INVENTION

This invention is directed to means and methods which enable thedisposal of various medically related articles by flushing inconventional toilet systems. The articles can be any relativelyflexible, soft objects such as ostomy pouches, wound dressings,bandages, diapers, sanitary napkins, tampons, etc. This result isaccomplished by totally covering the article with a slimy layer whichlubricates the article so that it can slip past close contact points andaround bends in going from the toilet bowl to the trap, through thetrap, and into the waste line. The slimy layer also helps wet down thesurface of the article increasing its softness and flexibility and thusenhancing its flushability.

A convenient and preferred way to create such slime layers is to coveror enclose the article to be flushed with a dry film or sheet ofmaterial which rapidly becomes slimy or exudes a slimy material oncontact with the water in a toilet bowl. For example, the article to beflushed is wrapped within a sheet of such material or placed within abag or sleeve formed from such material.

Another method is to add liquid or solid surfactants and/or softeningagents directly to the water within the toilet bowl or water tank in acontinuous manner. Another method is to coat the surface of the articlewith such surfactants and/or softening agents. Suitable surfactantsand/or softening agents include a 1:1 stearic acid monoethanolamide;glycerol; blends of ammonium alkyl ether sulfate, ammonium alkylsulfate, sodium alkyl glyceryl ether sulfonate, and coconut alcohols astaught by Rose et al. in U.S. Pat. No. 3,793,233; and blends ofmagnesium salts of ethoxylated, sulfated coconut alcohols and long chainalkyl sulfates, dimethylalkyl amine oxides, ethoxylated alcohols and/orphenols as taught by Hellyer et al. in U.S. Pat. No. 4,133,779 andPancheri in U.S. Pat. No. 4,316,824. Suitable commercially availablesurfactant compositions include various dishwashing detergents such asIvory® and Joy® both available from Procter and Gamble Co., Cincinnati,Ohio. Thus, flushability is enhanced by placing from about 1/4 ounce toabout an ounce of dishwashing detergent on the exposed surface of thearticle.

According to the preferred method, the article to be flushed is wrappedor placed within a sleeve or bag formed of material which will softenand form a slimy layer on the article when contacted with the water in aconventional toilet bowl. FIG. 1 shows a bag 60 constructed to beslightly larger than the article to be flushed. The bag is sealed onthree sides with an open mouth. The bag is constructed by folding asheet of suitable material and heat sealing along the two side edges 62and 63. When folded over, one wall can be slightly longer so as to aidthe user in opening the bag. Bag 60 can include one or more apertures 61in either or both bag walls so as to enable trapped air to escape fromthe bag. Alternatively, the bag can be constructed from materials of anopen mesh structure thereby obviating the need for apertures. While abag 60 has been shown, the same material can be formed into a sleeve bysealing the material into a tube configuration and then cutting to thedesired length.

Material suitable for use in forming bag 60 or the alternate sleeve orwrap include polyvinyl alcohol, polyethylene oxide, polypropylene oxide,polyethylene glycol, co-polymers of ethylene oxide and propylene oxide,carboxymethylcellulose, hydroxyethylcellulose, hydroxypropylcellulose,polyacrylamides, surfactant and/or softening agent impregnated tissuepaper, and highly absorbent tissue paper which is preferred in sometoilet systems of the washdown type which lack a vortex. Among thesematerials, the preferred in vortex toilet systems is a film of coldwater soluble polyvinyl alcohol of about 0.6 mils thickness. A suitablecommercially available cold water soluble polyvinyl alcohol film isavailable with an embossed pattern from Nippon Gohsei under theirtradename Hi-Selon AH 15. Embossing results in a film of greaterflexibility and softness.

Of course, in toilet systems prone to clogging, it may be desirable toboth place the article to be flushed within bag 60 or an equivalentsleeve and then also add solid or liquid surfactants and/or softeningagents to the toilet bowl prior to flushing. Alternatively, if thearticle within bag 60 fails to clear the bowl or trap on the firstflush, the surfactant and/or softening agent composition can then beadded to the toilet bowl prior to the second flush.

The means and methods described above are useful in flushing variousarticles including conventional ostomy pouches. However, such pouchesare normally formed from hydrophobic polymeric materials or laminatesand after flushing would tend to clog residential and commercial wastedisposal systems. Also, their accumulation would eventually impede thefunction of septic systems. Thus, there is a need for an ostomy pouchwhich after flushing will break apart or tear into small pieces on itspassage through the waste disposal system or will eventually degrade bynatural processes.

Suitable ostomy pouches which accomplish these results are shown inFIGS. 2 to 8. The flushable ostomy pouch 10 of this invention as shownin FIGS. 2 and 3 consists of front panel 12 and rear panel 32 heatsealed around their periphery to each other by the bond 14. The termfront panel is used to designate that portion of the pouch which in useis closest to the body.

As best shown in FIG. 2, the front panel includes an opening 16 whichfunctions as a starter hole. The user enlarges this opening by cuttingso as to fit the pouch over and around the stoma. Of course, the pouchcould be provided with pre-cut openings of various sizes. The stoma canthus protrude into the interior of the pouch. Front panel 12 is formedas a laminate of layers 18 and 19 and as best shown in FIG. 6 rear panel32 is a laminate of layers 33 and 34. Layers 19 and 33 are to theexterior of the pouch when the front and rear panels are joined. Thus,layers 18 and 34 will constitute the pouch interior.

Pouch 10 in order to be disposable by flushing must be soft and pliableor capable of becoming soft and pliable when contacted with the water inthe toilet bowl. However, at the same time, pouch 10 must be capable ofmaintaining its structural integrity during the normal period of use andmust be able to support the normal weight of fecal material that will bedischarged into the pouch. For a closed end colostomy pouch, the periodof use can extend from several minutes to about 24 hours and the load offecal material can be as much as about 250 grams. The pouch mustmaintain its integrity at body temperature and in the presence ofmoisture within the fecal material and perspiration that could permeatethe pouch from the exterior. Also, the materials employed must result ina pouch having adequate odor barrier properties during use and thematerials must be capable of being sealed so as to form the completedpouch. The cost and commercial availability of the materials are alsoimportant.

In addition to these properties for the overall pouch, material 19 whichcontacts the body of the user should feel comfortable and benon-irritating against the skin. Exterior material 33 which contacts theclothing of the user, should be relatively friction free so as tominimize any pulling on the pouch by clothing which could accidentlydislodge the pouch from the body.

Suitable materials for interior pouch layers 18 and 34 include filmswhich are water swellable but cold water insoluble such as hot watersoluble polyvinyl alcohol, which is preferred, amylose films,cross-linked polyacrylamides, and block copolymers of ethylene oxide andpropylene oxide. Water repellant tissue paper is the preferred materialfor body contacting layer 19 and water repellant tissue paper or anembossed film of cold water soluble polyvinyl alcohol are the preferredmaterials for clothing contacting outer pouch layer 33.

Attaching means 17 is included on the front pouch panel surrounding thestarter hole 16 for attaching the pouch directly or indirectly to thebody of the user. Preferably, as shown in the figures, attaching means17 also has a starter hole 16 and is affixed to the front panel so thatthe starter holes are aligned. As best shown in FIG. 4, attaching means17 includes a layer of pressure sensitive medical grade adhesive 24 thatis capable of forming a bond with the skin of the user of sufficientstrength to hold the pouch in place for from several hours to one ormore days. The body contacting surface of adhesive layer 24 is coveredprior to use by a sheet of silicone coated release paper 25.

As shown in FIG. 4, the adhesive layer 24 can be bonded directly to thesurface of tissue paper layer 19 by a combination of heat and pressure.Alternatively, as shown in FIG. 5, a backing film layer 23 can beinterposed between adhesive layer 24 and tissue paper layer 19.Preferably, film layer 23 is of a heat bondable or sealable materialsuch as hot water soluble polyvinyl alcohol or ethylene vinylacetate. Inthis case, a seal using heat, moisture, and pressure is made through thefront panel laminate thus bonding layer 23 onto layer 19.

FIG. 7 shows an alternate construction wherein the elements of attachingmeans 17 are not circular but include four extensions or tabs 26. Again,attaching means 17 includes an adhesive layer 24 and an optional backingfilm layer 23 of heat bondable or sealable material. In this embodiment,a heating tool having approximately the same diameter as that used informing the pouch of FIGS. 2-6 is employed. Thus, the tabs 26 are notattached to the front panel and the user can place his finger behind thetabs to press the pouch onto the body. At the same time, the area ofadhesive attachment to the body is increased so as to increase thesecurity of the pouch on the body of the user. The periphery of the areaof bonding between layers 19 and 23 or 24 is represented by the dashedline 27 in FIG. 7.

As shown in FIG. 2, front panel 12 can also include one or moreperforations 21 which are placed to overlie a layer of deodorizingfilter material 11. Of course, the perforations could be made in therear panel in which case the flatus gas would be vented away from thebody of the user.

Material 11 preferably contains activated carbon as a gas adsorbing anddeodorizing agent. One type of suitable material is a sheet of foamedopen-cell non-woven synthetic polymeric material, for example,polyurethane, having a large number of activated carbon particlesdistributed over one of its major surfaces. Such a material iscommercially available under the tradename Bondina. Another type ofsuitable deodorizing material is a felt pad or paper impregnated withactivated carbon in fine particulate form. Various types of such carboncloths and papers are commercially available.

As shown in FIGS. 2, 3, 7 and 8, a bar weld 15 of an arc configurationseparates filter 11 from the main portion of the pouch. A gap 13 of fromabout 1/8 to about 1/4 inch is provided between one end of the weld 15and the outer peripheral pouch weld 14 that joins front panel 12 andrear panel 32. The other end of weld 15 passes through or ends at theperipheral pouch weld 14. The gap is of sufficient size so that gaspassing from the stoma into the pouch can travel into contact withfilter 11. The gas then passes through filter 11 where it is deodorizedand exits the pouch through apertures 21 in front panel 2. The locationof gap 13 at the upper end of the pouch minimizes the possibility offecal matter contacting and clogging the filter material or escapingthrough apertures 21, and the bar weld prevents any carbon that flakesfrom filter 11 from contacting the stoma.

Front and rear pouch panel laminates are preferably both formed fromwater repellent tissue paper and hot water soluble polyvinyl alcoholfilm joined by a polyurethane adhesive according to well knownlaminating procedures. The hot water soluble polyvinyl alcohol films 18and 34 are selected so as to dissolve in water at a temperature of fromabout 140° F. to about 200° F., preferably about 160° F. Thus, the filmmaterials 18 and 34 will not dissolve at body temperature and willremain intact in the presence of perspiration or moisture that mightseep through the tissue paper layers 19 and 33.

The water resistant tissue paper layers 19 and 33 provide strength forthe pouch. These paper layers prevent or at least sufficiently reducethe rate at which moisture from outside the pouch such as bodyperspiration will contact the hot water soluble film layers. Also, thetissue paper on the front panel provides a more pleasant feel againstthe body than conventional polymeric ostomy pouch film. The use of hotwater soluble polyvinyl alcohol film material for layers 18 and 34prevents the pouch from dissolving or bleeding through due to moisturewithin the fecal material collected in the pouch. Also, the hot watersoluble polyvinyl alcohol film material maintains its structuralintegrity in the presence of small amounts of water or perspiration thatmay pass through the outer water resistant tissue paper layer.

The preferred laminate structure of water resistant tissue paper and hotwater soluble polyvinyl alcohol results in a pouch having adequate odorbarrier properties during the normal period of use in contrast topolyvinyl alcohol films which themselves lose their odor barrierproperties when wet. Of course, the tissue paper prevents skindiscomfort normally associated with direct contact with polyvinylalcohol films. Also, the laminate structure results in a pouch thatmaintains its structural integrity under a range of use conditionswhereas pouches formed only of hot water soluble polyvinyl alcohol willdistort under load.

The interior surfaces of the hot water soluble polyvinyl alcohol films18 and 34 are preferably coated or dusted with corn starch. Thisprevents or reduces the tendency of these film layers to seal togetherwhen the pouches are stored overtime in a package. The corn starch alsoapparently increases the slip between the hot water soluble polyvinylalcohol film and the fecal material entering the pouch so that thematerial will more readily pass to the bottom of the pouch away from thestoma. Preferably, the dusting is done just prior to the joining of thefront and rear pouch panels.

A suitable commercially available water resistant tissue paper for useas layers 19 and 33 is sold by the James River Corporation ofGouverneur, N.Y. under their code 35707. A suitable commerciallyavailable hot water soluble polyvinyl alcohol for use as layers 18 and34 in front panel laminate 12 and rear panel laminate 32 as well as foroptional adhesive backing layer 23 is available from the Mono-SolDivision of Chris-Craft Industrial Products under their code PVA 1000.This material becomes soluble in water heated to a temperature of above160° F. The laminate preferably consists of a single ply of waterresistant tissue paper and a film of hot water soluble polyvinyl alcoholof from about 0.5 to about 2.0 mils thickness. More preferably, the hotwater soluble polyvinyl alcohol will be a film of from about 0.8 toabout 1.25 mils thickness.

The pressure sensitive adhesive layer 24 preferably consists of one ormore water soluble or swellable hydrocolloids homogeneously dispersed inpolyisobutylene as taught by Chen in U.S. Pat. No. 3,339,546. Othersuitable hydrocolloid containing pressure sensitive adhesivecompositions are taught by Doyle et al. in U.S. Pat. No. 4,551,490. Theadhesive mass 24 is preferably extruded between two sheets of siliconecoated release paper 25, embodiment of FIG. 4, or is extruded onto asingle sheet of silicone coated release paper 25 and overlayed withbacking film layer 23, embodiment of FIG. 5. When cooled, this adhesivefaceplate is die cut to the circular shape with starter hole 16 as shownin FIGS. 2, 3 and 8 or is die cut to include tabs 26 and starter hole 16as shown in FIG. 7. Of course, the configuration of the adhesivefaceplate can be varied from those shown in the drawings. Preferably,adhesive layer 24 is from about 25 to about 35 mils thickness. Backingfilm layer 23, if present, is from about 0.8 to about 1.5 milsthickness.

The configuration of the ostomy pouch 10 can also be varied from thegeneral eliptical shape shown in the figures. In general, the pouch willvary in width from about 4 to about 6 inches and in length from about 7to about 10 inches so as to accomodate up to about 300 g. of stomaldischarge. The pouch could also be constructed in a smaller size forpediatric use. Of course, instead of the closed end pouch constructionshown in the figures, the same laminates could be employed to constructa flushable pouch having a drainable narrow open ended tail portion.This tail portion would then be sealed with a conventional clip typeclosure during usage. This clip could be flushable if made of anappropriate water soluble material such as polyethylene oxide. If madefrom conventional materials such as polyethylene, then the clip wouldnot be flushed with the pouch at the time of disposal.

The flushable ostomy pouch 10 can be assembled in an automated fashion.For example, a countinuous web of the front panel laminate 12 isadvanced with film layer 18 on the top. In the first operation, starterhole 16 and one or more apertures 21 are cut or punched out. In a secondoperation, the filter material 11 is attached to the front panellaminate. This is done by cutting the filter to shape, preferably acircular shape as shown in FIGS. 2 and 3, and coating one surface with aheat activatable adhesive. In fact, certain commercially availableactivated carbon filter materials come already coated with an adhesiveso that after cutting to shape all that is required is the removal of asheet of release paper. The filter 11 is then pressed against the hotwater soluble film layer 18 by a heated surface which bonds the filterin place overlying aperture 21.

At the same time, an adhesive faceplate assembly is cut to shape with astarter hole 16. The faceplate can be cut to the circular pattern shownin FIGS. 2, 3 and 8 or to the pattern including ear flaps 26 shown inFIG. 7. The adhesive assembly as shown in FIG. 4 having one surfacecovered with release paper is then passed under the web of front panellaminate 12 so that the starter holes 16 are aligned. An air piston toolhaving a circular shaped heat transfer surface is pressed down againstfilm 18 thus forming a heat seal between layer 19 and adhesive layer 24.Of course, in the embodiment of FIG. 7, the area of adhesive 24 outsidethe periphery of the heat seal bond 27 would bond adhesively to theouter layer 19 of the front panel. However, the user will be able topeel the adhesive material away from the front panel in this area at thetime of application of the pouch to the body.

When an adhesive assembly 17 including a backing layer 23 as shown inFIG. 5 is employed, the procedure is slightly different. The adhesivefaceplate assembly is moistened by spraying water onto the exposedsurface of film layer 23 or treating such surface with water vapor. Themoistened faceplate assembly is then passed under the web of front panellaminate 12 so that the starter holes 16 are aligned. An air piston typetool having a circular shaped heat transfer surface is pressed downagainst film 18 thus forming a heat seal between layers 23 and layer 19.Alternatively, the surface of layer 19 which is to contact the faceplateassembly can be moistened by spraying with water. In either case, thepresence of moisture enables the use of high enough temperature, i.e.,about 425° F., so as to form a true heat seal between layers 19 and 23.Of course, in the embodiment of FIG. 7 in which backing layer 23 ispresent, there would be no bond between layer 23 and front panel outerlayer 19 outside the periphery of the heat seal bond 27.

The resulting front panel web is mated with a web of the rear panellaminate 32 so that film layers 18 and 34 are facing one another. Apowdery atmosphere of corn starch is released so as to coat or dust thefacing surfaces of layers 18 and 34. A continuous heat seal is madejoining the two panels to form the pouch periphery 14 while at the sametime the panels are also joined along the arc line 15 leaving a gap 13.In the next operation the completed pouch is cut from the web. Ofcourse, the order of the operations described above can be varied. Forexample, the filter could be attached to the rear panel, or the pouchcould be outlined sealed and cut from the web in the same operation.

The ostomy pouch 10 has been shown as having an adhesive means forattachment to the body. However, attaching means 17 could be amechanical structure of polymeric material adapted to releasably couplethe pouch to an adhesive pad secured to the body. This body side padwould be provided with a mechanical structure that couples with thestructure on the pouch. Such a mechanical two-piece ostomy couplingsystem is shown by Steer, et al. in U.S. Pat. No. 4,460,363. Thus, thepolymeric channel shaped bag coupling element of Steer, et al. could beaffixed to front panel 12 around starter hole 16 by adhesive or othermeans. Such a pouch would be flushable if the channel shaped couplingelement is made of an appropriate water soluble material such as, forexample, polyethylene oxide.

The flushability of the pouch 10 can be enhanced by impregnating waterresistant tissue paper layer 19 as well as layer 33 if it is also formedfrom water resistant tissue paper with one or more surfactants and/orsoftening agents. These materials upon contact with the water in thetoilet bowl function to increase the rate at which the hot water solublefilm layers are softened by the water and in addition provide addedlubrication. Suitable materials for this purpose are as listed above.

The pouch 10 is disposed of by flushing in a conventional toilet.Preferably, the pouch and its contents are first placed within disposalbag 60. This should be done in a manner so as to avoid entrapping airwithin the pouch. One way to do this is to place the unfolded usedostomy pouch completely into the disposal bag bottom first, leaving theunsealed end of the disposal bag open. The disposal bag with theenclosed ostomy pouch is then placed into the water within the toiletbowl so that the stomal aperture 16 faces upward and is near the frontof the bowl. The toilet is then flushed. While in the toilet bowl theouter disposal bag 60 immediately begins to soften and dissolve to aslimy mass. This creates a completely lubricated outer surface on theused flexible ostomy pouch 10. The ostomy pouch then easily passes fromthe bowl, through the trap, and enters the waste line. The vortexcreated by flushing is sufficient to carry the disposal bag containingthe ostomy pouch and its contents through a conventional householdplumbing system. With empty or very lightly loaded pouches it may bedesirable to press the gas out of the pouch or puncture or cut the pouchin the area above the stomal opening prior to placement in the disposalbag so as to provide an additional exit for entrapped air. When toiletsof a non vortex, washdown type are used, it is also desirable to cut orpuncture the pouch in the area above the stomal opening. Over time,layers 18, 19, 23 (if present), 33, and 34 as well as adhesive mass 24will eventually disintegrate in a septic system.

Rather than cutting or puncturing pouch 10 to release entrapped air,pouch 10 could be provided with an integral tear strip in either thefront or rear panel laminates. Preferably, such tear strip would belocated just beneath the heat seal 14 at the top edge of the pouch, tothe side of gap 13. Such a tear strip could be constructed by embeddinga string within film layer 18 which partially extends through layer 19.The tear created should have a jagged edge since a smooth edge has atendency to reseal when the pouch becomes wet following placement in thetoilet bowl.

Another way of accomplishing this result is to include a V-shaped notchin the area of the top peripheral heat seal. Such a notch is shown asthe numeral 81 in FIG. 8. The notch provides an area of weakness whichthe user can employ to create a jagged tear across the top of the pouchprior to disposal. A heat seal bond 82 extends below the notch to insurethe integrity of the peripheral weld 14. Notch 81 and seal 82 can bemade at the same time as peripheral weld 14.

The following examples are illustrative of the invention.

EXAMPLE I

Pouches having the general configuration shown in FIGS. 2, 3, 5, and 6are prepared as follows. Front and rear panels are each a laminate of asingle ply of water resistant tissue paper (James River Corp., 35707)laminated by polyurethane adhesive to a 1.1 mil. thick film of hot watersoluble polyvinyl alcohol (Mono-Sol PVA 1000). The laminates are, ofcourse, sealed together so that the polyvinyl alcohol film layers formthe interior pouch surface. The stomal opening 16 is approximately 18mm. in diameter.

The adhesive attaching means 17 consisting of a layer of pressuresensitive adhesive 24 and a backing film layer 23 is prepared asfollows.

Layer 24 consists on a weight percent basis of the followingingredients:

Sodium carboxymethylcellulose: 22.17

Gelatin: 22.17

Pectin: 22.16

Polyisobutylene(available from Exxon as Vistanex LM-MH): 9.5

Polyisobutylene(available from Exxon as Vistanex L-100): 9.5

Mineral oil: 14.5

A premix of the two grades of polyisobutylene is prepared by masticatingthe L-100 to a fine shred in a Sigma blade mixer and blending with theLM-MH. A weighted amount of this premix is then placed into a mixer anda powdery blend of the gelatin, pectin, and sodiumcarboxymethylcellulose is added. Mixing is continued and the mineral oilis gradually added and incorporated into the mass. The mass is heated to80°-90° C. and extruded between a sheet of silicone coated release paperand 1.5 mils thick film of hot water soluble polyvinyl alcohol (Mono SolPVA 1000). The adhesive is of a thickness of about 25 mils. Theresulting attaching means 17 is cut into shape with an openingcorresponding to stomal aperture 16 and affixed to the tissue paperlayer of the pouch front panel by a combination of moisture, heat andpressure.

Bag 60 as shown in FIG. 1 is constructed by folding a sheet of embossedcold water soluble polyvinyl alcohol film (6 inch by 8 inch of 15 micronthick film of Hi-Selon AH-15 from Nippon Gohsei) over on itself and heatsealing the side edges to leave a 6 inch open mouth. No holes arepresent in the bag walls.

In these experiments, the pouches are filled with 150 grams of a blendof meat type dogfood and agar to simulate fecal material. The pouchesare flushed in various toilet systems both by merely placing the pouch10 in the toilet bowl by itself and by first placing the pouch within abag 60 and then placing the combination in the toilet bowl. The toiletis flushed immediately after the pouch or bag containing pouch is placedtherein. The pouch is considered to have successfully flushed if itpasses from the bowl and trap in three flushes or less and a failure ifthe water rises to or beyond the level of the rim of the toilet or thepouch fails to clear the bowl and trap after the third flush. Also,noted are any instances of transient blockage of the pouch in the toiletsystem which clears due to increased head from water back up in thebowl, i.e., spontaneous release.

    __________________________________________________________________________    TOILET SYSTEMS                                                                                                                      American                                    Mansfield                         Standard                        American Standard                                                                         Syphon Jet                                                                             Douglas-Leader                                                                             Manfield Quantum                                                                          Roma (Low Boy,                  Syphen Vortex                                                                             (3.5 gallon tank)                                                                      Washdown Syphon Jet                                                                        Water Saver (3.5 gallon tank)               (3.5 gallon tank)                                                                              Pouch                                                                             (5 gallon tank)                                                                            (1.4 gallon jet                                                                                Pouch)                     Pouch                                                                              Pouch  Pouch                                                                              within                                                                            Pouch Pouch  Pouch                                                                              Pouch  Pouch                                                                              within                     alone                                                                              within bag                                                                           alone                                                                              bag alone within bag                                                                           alone                                                                              within bag                                                                           alone                                                                              Bag                __________________________________________________________________________    Pouches Passed/                                                                       15/20                                                                              25/25  6/23 37/37                                                                             18/20 21/21  3/6  11/12  19/31                                                                              30/30              Pouches                                                                       Attempted                                                                     In the successes,                                                                     1 pouch                                                                            1 pouch-bag                                                                          2    0   2 pouches                                                                           3 pouch-bag                                                                          1 pouch                                                                            2 pouch-bag                                                                          1                                                                                  0ouch              the number                                                                            required                                                                           combination                                                                          pouches  required                                                                            combinations                                                                         required                                                                           combinations                                                                         required                requiring                                                                             2 flushes                                                                          required                                                                             required 2 flushes                                                                           required                                                                             2 flushes                                                                          required                                                                             2 flushes               multiple     2 flushes                                                                            2 flushes      2 flushes                                                                            and 1                                                                              2 flushes                      flushes to                                pouch                               clear bowl                                required                            and trap                                  3 flushes                           Successes with                                                                        2    0      2    2   5     0      0    3      7    2                  spontaneous                                                                   release                                                                       __________________________________________________________________________

EXAMPLE II

Pouches 10 and bags 60 are prepared identically to those described inExample I except that bag 60 has three apertures punched through bothbag walls. In these experiments, the load within the pouches are varied.

    __________________________________________________________________________    MANSFIELD SYPHON JET (3.5 gallon tank)                                                POUCH ALONE                POUCH-BAG COMBINATION                                                Number of passes            Number of passes                     Number of passes                                                                           with spontaneous                                                                            Number of passes                                                                            with spontaneous        Load    Pass rate                                                                          requiring multiple flushes                                                                 release  Pass Rate                                                                          multiple flushes                                                                            release                 __________________________________________________________________________    250 g.  --   --           --       2/3  1 pouch-bag combination                                                                     2                                                               required flushes                      200 g. +                                                                              --   --           --       5/5  0             0                        50 cc. of water                                                              225 g.  --   --           --       10/10                                                                              0             2                       200 g.  --   --           --       10/10                                                                              0             5                       175 g.  --   --           --       10/10                                                                              0             2                       150 g.  6/23 2 pouches required                                                                         2        10/10                                                                              0             0                                    2 flushes                                                         50 g.  --   --           --       10/10                                                                              3 pouch-bag combinations                                                                    0                                                               required 2 flushes                     25 g.  --   --           --       10/10                                                                              2 pouch-bag combinations                                                                    0                                                               required 2 flushes                     12 g.  --   --           --       --   --                                     0 g.   5/5  4 pouches required                                                                         0        5/5  3 pouch-bag combinations                                                                    0                               (inflated)                                                                         2 flushes, 1 pouch    (infla-                                                                            required 2 flushes                                 required 3 flushes    ted) (two noticeable backups)                                                 5/5  1 pouch-bag combination                                                                     0                                                          (air required 2 flushes                                                       pressed                                                                       out)                                       __________________________________________________________________________

    __________________________________________________________________________    DOUGLAS-LEADER WASHDOWN SYPHON JET (5 Gallon tank)                            POUCH ALONE                       POUCH-BAG COMBINATION                                Number of passes                                                                           Number of passes Number of passes                                                                           Number of passes                                                              with                      Load                                                                              Pass rate                                                                          requiring multiple flushes                                                                 with spontaneous release                                                                  Pass rate                                                                          requiring multiple                                                                         spontaneous               __________________________________________________________________________                                                        release                   150 g.                                                                            18/20                                                                              2 pouches required                                                                         0           10/10                                                                              1 pouch-bag combination                                                                    0                                  2 flushes                     required 2 flushes                      25 g.                                                                            --   --           --          10/10                                                                              1 pouch-bag combination                                                                    0                                                                required 2 flushes,                                                           1 pouch-bag combination                                                       required 3 flushes                      12 g.                                                                            --   --           --          12/13                                                                              3 pouch-bag combinations                                                                   0                                                           (air not                                                                           required 2 flushes,                                                      pressed                                                                            1 pouch-bag combination                                                  out) required 3 flushes                      0  --   --           --           9/10                                                                              3 pouch-bag combinations                                                                   0                                                           (air required 2 flushes                                                       pressed                                                                       out)                                        __________________________________________________________________________

    __________________________________________________________________________    AUSTROVIT P TRAP BOWL                                                         (no vortex washdown, turbulent flush, about 3 inches of water in bowl),       equipped with Gebberit 9 liter, plug type valve tank                          POUCH ALONE                       POUCH-BAG COMBINATION                               Number of passes                                                                           Number of passes  Number of passes                                                                           Number of passes                                                              with                      Load                                                                             Pass rate                                                                          requiring multiple flushes                                                                 with spontaneous release                                                                   Pass rate                                                                          requiring multiple                                                                         spontaneous               __________________________________________________________________________                                                        release                   150 g                                                                            13/13                                                                              0            0            3/3  0            0                          25 g                                                                            3/3  0            0            1/1  0            0                          12 g                                                                            1/1  1 pouch required                                                                           0            4/4  3 pouch-bag combinations                                                                   0                                 3 flushes                      required 3 flushes                      0 0/2                            0/2                                                                           (inflated)                                   0 1/1  1 pouch required                                                                           0            3/3  2-pouch-bag combinations                                                                   0                            (air 2 flushes                 (air required 2 flushes                        pressed                        pressed                                        out)                           out)                                        __________________________________________________________________________

EXAMPLE III

Pouches are prepared from the front and rear panel laminates andadhesive attaching means described in Example I except that theattaching means is of alternate configuration shown in FIG. 7. Bags 60are prepared as described in Example II, i.e., with three apertures. Inthese experiments the load within the pouches are varied.

    __________________________________________________________________________    AMERICAN STANDARD SYPHON VORTEX   MANSFIELD SYPHON JET                        (3.5 gallon tank)                 (3.5 gallon tank)                           POUCH-BAG COMBINATION             POUCH BAG COMBINATION                                Number of passes                                                                           Number of passes Number of passes                                                                           Number of passes                                                              with                      Load                                                                              Pass rate                                                                          requiring multiple flushes                                                                 with spontaneous release                                                                  Pass rate                                                                          requiring multiple                                                                         spontaneous               __________________________________________________________________________                                                        release                   150 g.                                                                            3/3  0            0           5/5  0            0                          50 --   --           --          5/5  2 pouch-bag combinations                                                                   0                                                                required 2 flushes                      25 g.                                                                            --   --           --          4/4  0            0                          0  3/3  1 pouch-bag combination                                                                    0           5/5  4 pouch-bag combinations                                                                   0                                  required 2 flushes       (air required 2 flushes                                                       pressed                                                                            1 pouch-bag combination                                                  out) required 3 flushes                     __________________________________________________________________________

EXAMPLE IV

In this experiment, a commercially available colostomy pouch with an 18mm. opening (ConvaTec's Active Life One Piece Closed-End Pouch With SkinBarrier) constructed from front and rear panels of a triple laminatecomposed of an outer and inner layer of ethylene vinylacetate and a coreof a copolymer of vinyl chloride and polyvinylidene chloride containinga load of 150 g. is placed within a bag 60 constructed as described inExample II with three apertures, and flushed in a Mansfield Syphon Jet(3.5 gallon tank) system. The pouch-bag combination flushed on the firsttry. However, there was spontaneous release, i.e., transient blockagewhich cleared due to increased head from water backup in the bowl.

EXAMPLE V

In this experiment, pouches are constructed as described in Example I,filled with 150 g. load, wrapped within an embossed warm water solublepolyvinyl alcohol film (1 mil. thick, Hi-Selon H-25 available fromNippon Gohsei Company), and flushed in an American Standard Roma (LowBoy, 3.5 gallon tank) toilet system. Two runs were made and both wrappedpouches were flushed on the first try with no spontaneous release noted.

EXAMPLE VI

In this experiment, pouches are constructed as described in Example I.The empty pouches are placed within a sleeve formed by heat sealing asheet of embossed cold water soluble polyvinyl alcohol film (6 inch by 8inch of 15 micron thick film of Hi-Selon AH-15 from Nippon Gohsei) sothat both 6 inch sides remain open. Three runs were made by flushing theempty pouch-sleeve combination in a Mansfield Syphon Jet (3.5 gallontank) system. Two pouch-sleeve combinations required two flushes and theother required three flushes to clear the bowl and trap. No instances ofspontaneous release were noted.

EXAMPLE VII

In this experiment, pouches are constructed as described in Example Iexcept that no filter element 11 is included and the stomal opening 16is 38 mm. in diameter. Each pouch is filled with a load of 150 g. andaged overnight. The filled pouch is then placed in the bowl of aMansfield Syphon Jet (3.5 gallon tank) and a measured quantity ofsurfactant and/or softening agent is added one minute prior to flushing.

    __________________________________________________________________________    Surfactant               Number of passes requiring                                                                  Number of passes with                  and/or softening agent                                                                     Amount used                                                                          Pass rate                                                                          multiple flushes                                                                            spontaneous release                    __________________________________________________________________________    none          --    18/34                                                                              10 pouches required                                                                         6                                                               2 flushes                                            glycerine    15 cc. 3/3  1 pouch required                                                                            1                                                               2 flushes                                            1:1 stearic  about  6/6                3                                      acid monoethanolamide                                                                      15 g.                                                            (available from Mona                                                          Ind. as Monamid S)                                                            Ivory ®  15 cc   8/10                                                                              3 pouches required                                                                          4                                      dishwashing liquid       2 flushes, 1 pouch                                   (Proctor and Gamble,     required 3 flushes                                   U.S. Pat. No. 3,793,233)                                                                   30 cc  4/4  1 pouch required                                                                            3                                                               3 flushes                                            Joy ®     5 cc  4/5  3 pouches required                                                                          1                                      dishwashing liquid       2 flushes                                            (Proctor & Gamble,                                                            U.S. Pat. No. 4,133,779                                                                    15 cc  26/29                                                                              6 pouches required                                                                          5                                      and 4,316,824)           2 flushes                                            Monaterge LF-945                                                                            5 cc  3/5  --            2                                      (a blend of nonionic,                                                                      15 cc  16/18                                                                              5 pouches required                                                                          7                                      amphoteric surfactants   2 flushes                                            available from Mona Ind.)                                                     __________________________________________________________________________

What is claimed is:
 1. An ostomy pouch which can be disposed of byflushing in a conventional toilet bowl comprising a front panel formedof a laminate of a film of water swellable, cold water insoluble, hotwater soluble polyvinyl alcohol and water resistant tissue paper and arear panel formed of a laminate of a film of water swellable, cold waterinsoluble, hot water soluble polyvinyl alcohol and either waterresistant tissue paper or a film of cold water soluble polyvinyl alcoholboth of which are relatively friction free when contacted with theclothing of the user, said front and rear panels joined together over amajority of their periphery to form said ostomy pouch, said front andrear panels oriented so that said films of hot water soluble polyvinylalcohol constitute the pouch interior, said front panel having anopening therethrough that can fit or can be enlarged to fit around thestoma, and attachment means secured to said front panel around saidstomal opening for attachment of said pouch to the body of the userwherein said pouch is capable of maintaining its structural integrityduring the period of use.
 2. The pouch of claim 1 wherein said front andrear panel laminates both are formed of a film of hot water solublepolyvinyl alcohol of from about 0.5 to about 2.0 mils. thickness and asingle ply of water resistant tissue paper laminated together by apolyurethane adhesive.
 3. The pouch of claim 1 wherein said hot watersoluble polyvinyl alcohol films are from about 0.8 to about 1.25 milsthickness.
 4. The pouch of claim 1 wherein said attachment meanscomprises a layer of pressure sensitive adhesive secured directly to thewater resistant tissue paper layer of said front panel, and wherein saidadhesive layer includes an opening substantially similar to said frontpanel stomal opening that fits or can be enlarged to fit around thestoma.
 5. The pouch of claim 4 wherein the exposed surface of saidadhesive layer is covered by a sheet of release paper prior to use. 6.The pouch of claim 4 wherein said layer of pressure sensitive adhesivehas an outer periphery of a generally circular shape and is sealed byheat and pressure across its entire surface area to the water resistanttissue paper layer of said front panel.
 7. The pouch of claim 4 whereinsaid layer of pressure sensitive adhesive includes one or more portionswhich extend beyond the area sealed by heat and pressure to the waterresistant tissue paper layer of said front panel.
 8. The pouch of claim4 wherein said attachment means comprises a layer of pressure sensitiveadhesive and a backing film, said backing film secured directly to thewater resistant tissue paper layer of said front panel, and wherein saidadhesive layer and said backing film include an opening substantiallysimilar to said front panel stomal opening that fits or can be enlargedto fit around the stoma.
 9. The pouch of claim 8 wherein the exposedsurface of said adhesive layer is covered by a sheet of release paperprior to use.
 10. The pouch of claim 9 wherein said attaching means issecured over its entire surface area to said front panel.
 11. The pouchof claim 9 wherein one or more peripheral portions of said attachingmeans extend beyond the area in which said attachment means is securedto said front panel.
 12. The pouch of claim 1 wherein said front andrear panels are joined together around their entire periphery to form aclosed ended pouch.
 13. The pouch of claim 12 wherein a filter means isprovided in the pouch above the stomal opening in the front panel whenthe pouch is attached to a user.
 14. The pouch of claim 13 wherein saidfilter means contains activated carbon.
 15. The pouch of claim 14wherein said front and rear panels are joined in the area around saidfilter means so as to isolate said filter from the remaining portion ofsaid pouch except for a gap adjacent the peripheral seal at the top edgeof the pouch which permits gas to flow from the pouch to the filtermeans and prevents contact of the stoma with carbon material flakingfrom said filter.
 16. The pouch of claim 15 wherein said filter means isadhesively secured to one of said panels and one or more perforationsare present in the portion of one of said panels overlaying said filtermeans.
 17. The pouch of claim 1 wherein one or both of said waterresistant tissue paper layers are impregnated with a surfactant.
 18. Thepouch of claim 1, wherein a notch is provided in a portion of theperipheral bond between said front and rear panels at the top edge ofsaid pouch, said notch enabling the pouch after use to torn open acrossthe top prior to disposal.
 19. The pouch of claim 1 wherein a tear stripis provided in either the front or rear panel near the top edge of saidpouch, said tear strip enabling the pouch after use to be torn openacross the top prior to disposal.
 20. The method of disposing of a usedostomy pouch constructed in accordance with claim 19 comprising removingsaid pouch from the body, placing said pouch in a toilet bowl,contacting the exposed pouch surface in the toilet bowl with asurfactant containing composition, and flushing whereby the pouch andits contents will pass from the bowl.
 21. The method of claim 20 whereinthe pouch is perforated, cut, or torn after removal from the body in thearea above the stomal opening prior to placement in the toilet bowl. 22.The method of improving the flushability of an ostomy pouch constructedin accordance with claim 19 in marginally performing or clog pronetoilets by adding a surfactant and/or softening composition to the waterin the toilet bowl or to the cistern feeding the toilet bowl prior todisposal of the ostomy pouch.
 23. The method of disposing of a usedostomy pouch constructed in accordance with claim 19 comprising removingsaid pouch from the body, wrapping or completely enclosing said pouchwithin a material that becomes slimy or exudes a slimy material when incontact with the water in a toilet bowl, placing said wrapped orenclosed pouch into a toilet bowl, and flushing whereby said pouch andits contents pass from said bowl through the trap into the waste line.24. The method of claim 23 wherein the pouch is perforated, cut or tornafter removal from the body and prior to wrapping or enclosing withinsaid material.
 25. The method of claim 23 wherein said ostomy pouch isplaced within a bag or sleeve formed from highly absorbent tissue paper.26. The method of claim 23 wherein said ostomy pouch is placed with abag or sleeve formed from cold water soluble polyvinyl alcohol.
 27. Themethod of claim 26 wherein said ostomy pouch is placed with a bag formedfrom an embossed cold water soluble polyvinyl alcohol film of about 0.6mils. thickness.
 28. The method of claim 27 wherein said bag has one ormore apertures to aid in the release of entrapped air.
 29. The method ofclaim 23 wherein said ostomy pouch is placed within a bag or sleeveformed from tissue paper impregnated with a surfactant and/or softeningagent.
 30. The method of disposing of a used ostomy pouch comprisingremoving said pouch from the body, wrapping or completely enclosing saidpouch within a material that becomes slimy or exudes a slimy materialwhen in contact with the water in a toilet bowl, placing said wrapped orenclosed pouch into a toilet bowl, and flushing whereby said pouch andits contents pass from said bowl through the trap into the waste line.31. The method of claim 30 wherein said ostomy pouch is placed within abag or sleeve formed from highly absorbent tissue paper.
 32. The methodof claim 30 wherein said ostomy pouch is placed within a bag or sleeveformed from cold water soluble polyvinyl alcohol.
 33. The method ofclaim 32 wherein said ostomy pouch is placed within a bag formed from anembossed cold water soluble polyvinyl alcohol film of about 0.6 milsthickness.
 34. The method of claim 33 wherein said bag has one or moreapertures to aid in the release of entrapped air.
 35. The method ofclaim 30 wherein said ostomy pouch is placed within a bag or sleeveformed from tissue paper impregnated with a surfactant and/or softeningagent.